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Doctors Raise Questions Over Drug Trials in Developing Countries

From Guardian Web (June 13, 2012)

Senior doctors are claiming that some drug trials, carried out after a medicine has won its licence, are more to do with increasing sales than science.

One expert claims that these tactics, carried out in low income countries such as India where people have to pay for medicines, can cause "catastrophic health expenditure" for families when the patient has to take over the cost of treatment at the end of the trial period.

Post-marketing studies are often carried out even though they are not required by drug licensing authorities. After the tests required by medicines authorities which are under strictly controlled conditions, the idea is that drug companies and doctors can find out how well a medicine works in the real world, when patients are not so regularly monitored and supported.

But a paper published online by the British Medical Journal by Edwin Gale, emeritus professor of diabetic medicine at Bristol University, raises questions about the usefulness and real purpose of such trials.

Gale looked at post-marketing trials carried out by the manufacturers of new forms of insulin for people with type 2 diabetes. These so-called analogue insulins can cost up to four times as much as conventional human insulin, but the National Institute for Health and Clinical Excellence (Nice) which examined the data on them in the UK found they did not offer much more benefit for most people.

However, writes Gale, nearly 400,000 people have been recruited into post-marketing trials of these analogue insulins worldwide since 2005. Most of the studies were carried out in middle or lower-income countries and had limited scientific value, he alleges.

While doctors may take part in such a trial in good faith, "the patient or healthcare system pays for a more expensive agent instead of one that is cheaper and equally effective, and the public is offered misleading claims of comparative merit based on studies of limited scientific value," writes Gale.

Most people would be likely to remain on the new and far more expensive insulins at the end of the trial, says John Yudkin, emeritus professor of medicine at University College London in a second article. Such studies, he writes, "may be driving households into catastrophic health expenditure."


Posted: June 2012